Stopper



Mu'ci 23, 1948. F. A. CUTTER ETAL STOPPER Filed Dec. 18. 1945 INVENTORS FEED A. CUTTER Patented Mar. 23, 1948 sToPPEn Fred A. Cutter, Berkeley,

Oakland, Calif., assignors to Cutter Laboratories, Berkeley, Calif., a corporation of California and William F. Butler,

Application December 18, 1945, Serial No. 635,840 2 Claims. (Cl. 215-47) This invention relates to stoppers for flasks used for shipping, retaining and making intra-- venous injections.

All interior surfaces of flasks and Stoppers used for administering intravenous injections must be absolutely sterile and free of all foreign matter which might in any way react withthe contents of the flask. During recent years we have found that, although biologic solutions, such as glucose and saline solutions, are crystal clear when bottled, upon standing they become contaminated with a precipitate. The reasons for this have been found to be twofold. In the first place, a1- though the quality of glass is constantly being improved it is still not entirely inert to some biologic solutions. In the second place, the only stoppers available have been made of rubber containing a filler which, upon standing in contact with biologic solutions, is leached out and produces a precipitate. Although in some cases the quantity of precipitate is extremely small and results in no injury to the patient, the Pure Food and Drug Commission, nevertheless, requires that such solutions be crystal clear.

In an attempt to avoid the formation of such precipitates, the stoppers have been thoroughly washed in both acid and alkaline solutions but, in spite of this, precipitates still form. Another expedient resorted to in an attempt to overcome this problem was to coat the exposed surface of the stopper with material inert to the solutions in question. This coating was applied by passing the stoppers through a plurality of opposed pairs of sprays and rotating `the Stoppers during their passage through the sprays. However, stoppers used for this purpose are provided on their lower ends with one or more upwardly extending, straight walled, circular recesses through which access is had to the interior of the flasks. It was found that, because of these recesses, it was impossible eiectively to coat the Stoppers, regardless of the number of sprays used and regardless of the fact that they were rotated during their passage between the sprays. Furthermore, these recesses, which are relatively deep, made it impossible thoroughly to wash the Stoppers prior to applying them to their flasks.

Access through this type of stopper is had by passing a hypodermic needle therethrough, the needle being connected through a suitable tubing and a hypodermic needle on its free end with the patient. This method of gaining access to the interior of the flask has the advantage that if the depth of the stopper through which the needle passes is suiilciently long, the incision made by 2 the Vhvpodermic needle is automatically sealed when the needle is withdrawn. It has been found, however, that when a hypodermic needle is injected through a stopper in a direction substantially transverse-to the face thereof, a small core, having a depth substantially equal to the internal diameter of the needle, is cut from the stopper and either blocks the stopper or restricts the flow of the liquid therethroug Flasks and stoppers ofthe character under discussion' are frequently used for receiving blood from a donor and for subsequently administering such blood to a patient. When used for this purpose, the iiask is provided with a small quantity of a blood non-coagulant such as sodium citrate. Although the sodium citrate decreases the formation of blood clots, it does not altogether prevent it and, on occasions, these clots. due to the construction of the stopper and method of making the discharge connection therewith, restrict or block the ilow of blood from the flask.

One of the objects of this invention is the provision of a stopper formed on its inner surface with an outwardlydiverging recess capable of being effectively coated with an inner coating, into which the inner end of a glass nipple may be inserted and whichserves as a sump surrounding the end of the nipple for the reception of any blood clots which may settle on to the inner end of the stopper when the flask isv in an inverted position. l

A further object of the invention is the provision in a stopper of the character described of an elongated hypodermic needle entrance recess disposed over an inclined portion of the lower end of the stopper so -that an attendant can selectively insert the hypodermic needle through a portion of the stopper of predetermined and variable thickness.

The invention possesses other advantageous features, some of which with the foregoing will be set forth at -length in the following description where that form of the invention which has been selected for illustration in the drawings accompanying and forming a part of the present speciilcation is outlined in full. In said drawings, one

form of the invention has been illustrated, but it is to be understood that it is not limited to such form, since the invention as set forth inthe claims may be embodied in a plurality of other forms.

Referring to the drawings: Figure 1 is a vertical midsection an inverted ask and its stopper objects of our invention have been taken through in which the embodied.

Stopper l,

ing recess 5, defined by a generally vertical wall` lower end with an upwardly 6, merging at its inclined wall 1. The outer end of the stopper is formed with an inwardly extending recess 8 in registration with the innermost portion of the recess 5 and which is separated from the latter recess by a relatively thin diaphragm 9. The diaphragm 9 is of such thickness that `it can be Vreadily ruptured by a hypodermic needle to rethe tapered end ceive and permit the passage of II of a glass nipple I2, the free outer end of the nir-pple being connected with a suitable rubber tube or ahose .13. .Y i

Also textending into the stopper from its inner face is a circular opening I4 for theforce-t reception of an rair-.eduction tube I5.

Vsprayed over the entireinner surface of the including cess 5, is a lm or coating I6 of any Ysuitable material inert to the biologic solutions contained in the ask, there being many such materials available .on the .open market for this purpose,

Extending downwardly from the outer' face of the `stopper is an elongated, slig-htlyarcuate hypodermic needle entrance recess I l, the bottom of which is V-.shaped yin .cross-section, as shown in Figure l. By inserting a hypodermie needle into the recess I1 and injectingvr the needle through the stopper at this zone, the formation of a core is yobviated :due to the inclined inner V-shaped walls of the recess I'I. From Figure 1, it is to be noted that the 4recess Il is in vertical alignment with the inclined walll of the recess 5, and from Figure v2, it will be noted that the depth of material through the stopper increases from point A to point point C. The eiectiveness with which an incision made through a stopper ,is vautomatically 4sealed when Ithe hypodermic needle is withdraw-.n depends upon the depth vof material through which the needle penetrates. Since for this reason some medical branches of the armed services require a greater depth of material at this point than 4do other branches, it has been necessary in the past to vprovide the armed services with Stoppers made in accordance with various speciiications. However, by resorting vto the expedient above described, a standard stopper can be made to comply with all of the specications in question for the doctor or attendant to select the depth of material through which the needle is made to pass. Conveniently the points A, B and C can be Idesignated in terms of the actual number of the inwardly divergent re-V B, and from. point B to,

millimeters throughV which the needle passes at these points.

Y In une with the tube 15 on the outer face of the stopper is a small indentation or recess I8 serving to locate that point on the outer face of the stopper through which a hypodermic needle must rbe inserted "In order to penetrate into the tube I5 .for establishing communication between the interior of the flask 4 and atmosphere.

From the above description, it will be noted that: The outwardly divergent recess.5 permits the entire exposed lower portion of the stopper effectively to be coated with a protective lm inert to the contents of the flask and that this recess defines a* blood clots which ymay settleto the inner end vof the stopper. The arcuate inwardly convergent vrecess IFI avoids the formation of any core when a hypodermic needle is injected through the stopperrat any point along this zone and,` due to the fact that the depth of the stopper varies along the length of the recess Il, an operator or attendant can select the depth .of the stopper through which he desires topass the .hypodermic needle so as to comply with the varyingregula- Y tions of the diierent medical units.

We claim:

1. A stopper `designed .for use in conjunction with a` flask for making intravenous injections, the upper surface of said stopper being formed with a transversely elongated .and downwardly converging hypodermic needle `entrance channel and said stopper vbeing of vais/ing depth at points along said channel.

2. .A stopper for use in Yconjunction with a flask for making intravenous injections, the inner end of said stopper being formed with an outwardly diverging recess arranged to receive and accommodate the inner end of a connecting nipple, and which serves as Aa sump immediately adjacent the inner end of saidnipple'for Ythe reception of solid matter when the .stopper is in an inverted position, the outer end of said .stopperV being `formed with a transversely elongated and downwardly converging hypodermic Vneedle entrance channel overlying said. recess, and wherein the depth of said stopper varies along `said channel.

Vliltlill) A. CUTTER.

WILLIAM F. BUTLER.

REFERENCES CITED The following references are of record in the file of this patent:

UNITED STATES PATENTS 2,231,418 Trotter n n- 7.--- Feb. 11, 1941 sump for the reception of ant7 I 

